NUTRITION
FOOD SAFETY
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Question
[CLICK ON ANY CHOICE TO KNOW THE RIGHT ANSWER]
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Once each year
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Once every two years
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Once every three years
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Once every five years
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Detailed explanation-1: -All high-risk domestic facilities must be inspected within five years of enactment and no less than every three years thereafter. Within one year of enactment, the law directs the FDA to inspect at least 600 foreign facilities and double those inspections every year for the next five years.
Detailed explanation-2: -FDA conducts several types of inspections to help protect consumers from unsafe products: pre-approval inspection after a company submits an application to FDA to market a new product. routine inspection of a regulated facility. “for-cause” inspection to investigate a specific problem that has come to FDA’s attention.
Detailed explanation-3: -If the audit meets the criteria for an MDSAP 5-day Notice, the complete audit report package is to be provided to the regulatory authorities before D0+45 calendar days. In all other cases, the complete audit report package is to be provided to the regulatory authorities before D0+90 calendar days.
Detailed explanation-4: -There are 2 basic types of FDA inspections: Surveillance inspection-is routine FDA inspection, whereas the compliance inspection is based on specific objective, such as compliant or other suspected specific problem like unreported Adverse Events (AEs).